Opioid-Related Disorders Clinical Trial
— STUD_TOXOfficial title:
Evaluation of Pharmacy Students' Perception of Opioid / Opiate Dependence: Cross-sectional National Study
NCT number | NCT03859778 |
Other study ID # | CHU-427 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 14, 2019 |
Est. completion date | March 31, 2019 |
Verified date | February 2019 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The pharmacist in his professional activity may have to manage opioid dependent patients.
This professional activity will result in the provision of opioid substitution treatment
(OST), single-use syringes, harm reduction kits and a prevention advice for the reduction of
toxicity and infection risks.
Since the 1990s, the consumption of OST has been steadily increasing. According to the OFDT
(French Observatory of Drugs and Drug Addiction), the number of patients under OST is about
150 000 patients. Since high-dose buprenorphine is prescribed for approximately two-thirds of
patients, it remains the most frequently prescribed OST in France.
Recently, a French association assisting drug users (ASUD - Auto-support des usagers de
drogues) performed a study in Paris (20/07/2018 - 25/08/2018) to assess the delivery of
opioid replacement therapies by community pharmacists. In this study, 71% of pharmacists
refused to deliver opioid replacement therapies. The main reasons reported were security
(56%) and activity saturation, meaning that pharmacists considered that they had too many
patients using opioid drugs. In France, the refusal of a pharmacist to deliver drugs is a
punishable offence. According to the Code of ethics of pharmacists, pharmacists must respect
life and people without discrimination. Pharmacists have a low perception of patients
suffering from opioid addiction. Another study performed by ASUD in 93 community pharmacies,
showed that pharmacists used the term "toxicomaniacs" instead of "drug users". Most
pharmacists had had a bad experience with drugs users, with physical and verbal aggressions.
The conclusions of this study showed that pharmacists lacked knowledge of drug users and drug
use. Pharmacists knew about harm reduction kits for opioid users (containing sterile
syringes, needles, water, antiseptics, etc.) and had already opened them, but very few knew
how to use them. More worryingly, some pharmacists did not understand the harm reduction
strategies available It thus appears that community pharmacists have a difficult relationship
with opioid-dependent patients, even though these pharmacists have received education in the
management of addictions during their studies. Indeed, it can consider that these courses
should help to better understand the addictive disease both in its nosological / semiological
and therapeutic components. Thus, it would be interesting to evaluate the impact of addiction
education on pharmacists' perception of opioid dependence. In this perspective, it would be
interesting to focus on pharmacy students.
The objective of this study will be to evaluate the perception by pharmacy students of opioid
dependent patients. Investigator would like to know if pharmacy students consider opioid
addiction to be an illness and whether having taken education on drug use and addictions
changes this perception.
Status | Completed |
Enrollment | 2034 |
Est. completion date | March 31, 2019 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - French pharmacy students Exclusion Criteria: - Age <18 years - Other health students - Graduated pharmacist - First year pharmacy student |
Country | Name | City | State |
---|---|---|---|
France | Chu Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | UFR Pharmacie (Clermont-Ferrand) |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perception of opioid / opiate dependence as a disease | visual analogic scale: -10 (it is not a disease), 0 (neutral) and +10(it is a disease) | At day 1 | |
Secondary | Proportion of courses on drug addiction during pharmacy studies | yes/no (percentage) | At day 1 | |
Secondary | Study year of courses on drug addiction during pharmacy studies | 2nd, 3rd, 4th, 5th and/or 6th year of study in pharmacy | At day 1 | |
Secondary | Perception of the pharmacist's missions on the dispensing of opioid substitution treatments (buprenorphine and methadone) and harm reduction kit / single use syringe | visual analogic scale: -10 (it's not normal), 0 (neutral) and +10 (it's normal) | At day 1 | |
Secondary | Perception of the efficacy of opioid substitution treatments (buprenorphine and methadone) | visual analogic scale: -10 (it is not effective), 0 (neutral) and +10 (it is effective) | At day 1 | |
Secondary | Proportion of realization of internships or temporary employment in pharmacy | yes / no (percentage) | At day 1 | |
Secondary | Proportion of delivery of opioid substitution treatments (buprenorphine and methadone) | yes / no (percentage) | At day 1 | |
Secondary | Proportion of tobacco (cigarettes) use | yes / no (percentage) | At day 1 | |
Secondary | Proportion of electronic cigarettes use | yes / no (percentage) | At day 1 | |
Secondary | Proportion of alcohol use | yes / no (percentage) | At day 1 | |
Secondary | Proportion of alcohol use (>10 alcohol units per week) | yes / no (percentage) | At day 1 | |
Secondary | Proportion of cannabis use | yes / no (percentage) | At day 1 | |
Secondary | Frequency of cannabis use (for users) | Daily, weekly, monthly, occasional or experimentation | At day 1 | |
Secondary | Proportion of personal experience with a relative having or having had a problem of drug use | yes / no (percentage) | At day 1 | |
Secondary | Academic year in pharmacy at the time of the answer | 2nd / 3rd / 4th / 5th / 6th year of study in pharmacy | At day 1 | |
Secondary | Estimation of attendance to courses | Visual analogic scale: 0 (no attendance) - 100 (full attendance) | At day 1 | |
Secondary | Estimation of annual average mark during the past university year | <10, 10-12, 12-14, 14-16 and >16/20 | At day 1 | |
Secondary | Demographic information | age and sex | At day 1 |
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